NKMAX's 'SNK01' Approved for US Alzheimer's Phase 1 and 2a Trial Plans

NK Max (NK Max) announced on the 25th that its subsidiary NK Gen Biotech has received approval from the U.S. Food and Drug Administration (FDA) for the clinical phase 1/2a plan (IND) of the autologous natural killer (NK) cell therapy 'SNK01' for Alzheimer's dementia.

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This clinical trial will proceed in the U.S. as phase 1/2a following the FDA's recognition of the phase 1 Alzheimer's clinical data conducted by NK Max in Mexico. In the Mexico trial, up to 4 billion SNK01 cells were administered, and in this U.S. trial, up to 6 billion SNK01 cells will be administered to explore the safety and efficacy of the dosage. Additionally, regarding the clinical subjects, while the previous Mexico trial included mild patients, this trial will target only moderate Alzheimer's patients. The trial will be conducted at four centers in the U.S., administering SNK01 a total of 17 times over 49 weeks to 36 moderate Alzheimer's patients.

SNK01 aims not only to assist in the removal of abnormal protein aggregates (plaques) such as amyloid-beta (Aβ) and tau, which existing antibody therapies focus on, but also to reduce neuroinflammation and improve the overall immune environment in the brain.

Paul Song, CEO of NK Gen Biotech, stated, “Most treatments focus on mild Alzheimer's disease, so there is currently no treatment method for patients with advanced disease,” adding, “Since the FDA suggested extending the dosing period to treat moderate Alzheimer's disease first, we expect SNK01 to demonstrate its potential in this clinical trial.”

Meanwhile, NK Max plans to present the final data of the Mexico Alzheimer's phase 1 clinical trial at the upcoming Clinical Trials on Alzheimer's Disease (CTAD) conference this month.

This content was produced with the assistance of AI translation services.